[This section was also part of the original document; it was split to keep the information more focused - Ed.]
Prescription and Over-the-Counter (OTC) Drugs
FDA is responsible for
determining the marketing status (prescription or over-the counter) of animal
drug products based on whether or not it is possible to prepare adequate
directions for use under which a layperson can use the drugs safely and
effectively. Products for which adequate directions for lay use can be written
must be labeled for over-the-counter (OTC) use under existing law. If adequate
directions cannot be written, the prescription (RX) system provides a method of
distribution and control which is intended to assure that the RX product reaches
only the hands of persons trained to use the product. This can include, in
addition to the veterinarian, animal owners or managers whom the veterinarian
has determined are capable of using the product safely under the practitioner's
supervision. Safe use includes safety to the animal, safety of food products
derived from the animal, safety to the person administering the drug, safety to
persons associated with the animal, and safety in terms of the drugs impact on
the environment. Effective use of a drug product assumes that an accurate
diagnosis can be made with a reasonable degree of certainty, that the drug can
be properly administered, and that the course of the disease can be followed so
that the success or lack of success of the product can be observed. The same
drug substances can be marketed in a number of different dosage forms, intended
for use by varying routes of administration, and in varying species of animals.
Thus, these drug products may be labeled RX in some cases and OTC in others.
Prescription products must be labeled as follows: Caution: Federal law restricts
this drug to use by or on the order of a licensed veterinarian. Since adequate
directions for safe and effective lay use cannot be written for veterinary
prescription drug products, such products can only be sold to or on the
prescription or other order of a licensed veterinarian. Sale of a veterinary
prescription drug product to a layperson, except on a prescription or on order
of a licensed practitioner, causes the product to be misbranded, and subjects
the seller to civil and/or criminal provisions of the Federal Food, Drug, and
Cosmetic Act. A licensed veterinarian may legally use or dispense a veterinary
prescription drug product only within the course of his/her professional
practice where a valid veterinarian-client-patient relationship exists.
Veterinarians employed by drug manufacturers or distributors may not legally
dispense prescription drug products to laypersons unless they meet the above
criteria. Similarly, practicing veterinarians or their employees may not legally
sell veterinary prescription drug products to walk-in customers unless a valid
veterinarian-client-patient relationship exists. Attached is a list of the drugs
that are currently approved for use in horses. It includes the active
ingredients and brand names of the drugs, and indicates whether the product may
be sold over-the-counter (OTC) or by prescription (RX). This is not intended to
be a complete list of active ingredients or brand names available on the market.
The brand names are used as examples only and their listing in no way implies
any product endorsement by the Food and Drug Administration. This listing is not
intended to serve as an official reference for firms or individuals dealing with
the Agency.
DRUGS APPROVED FOR HORSES ACTIVE INGREDIENTS / BRAND NAMES INJECTABLE USE Acepromazine Maleate Prom Ace Injectable (RX) Promazine Injectable (RX) Alfaprostol Alfavet (RX) Altrenogest Regu-Mate Solution (RX) Aminopromazine Fumerate Jenatone Solution (RX) Ampicillin Sodium Amp-Equine (RX) Benzathine Penicillin G Benza-Pen (R/O) Procaine Penicillin G Bicillin Fortified (RX) Depo Pen (R/O) Longicil Fortified (RX) Flo-Cillin/Dura-Biotic (R/O) Betamethasone Acetate Betavet Soluspan Betamethasone Disodium Suspension (RX) Phosphate Betamethasone Dipropionate Betasone Aqueous Betamethasone Sodium Suspension (RX) Phosphate Boldenone Undecylenate Equipoise (RX) Butorphanol Tartrate Torbugesic (RX) Ceftiofur Sodium Naxcel Inj. (RX) Chloral Hydrate Chloropent (RX) Magnesium Sulfate Pentobarbital Detomidine Hydrochloride Dormosedan (RX) Dexamethasone Azium Aqueous Suspension (RX) Azium Solution (RX) Dexachel (RX) Dex-A-Vet (RX) Dexamethasone Injection (RX) Dexamethasone Solution (RX) Zonometh Solution (RX) Dexamethasone Phosphate Dexamethasone Injection (RX) Dexamethasone Sodium Dex-A-Vet Injection (RX) Phosphate Dexamethasone Injection (RX) Dexamethasone-Voren Suspension (RX) -Isonicotinate Dihydrostreptomycin Sulfate Dihydrostreptomcycin (RX) Pfizer-Strep (RX) Dinoprost Tromethamine Lutalyse Sterile Solution (RX) Prostin F2 Alpha (RX) Doxapram Hydrochloride Dopram-V Injectable (RX) Doxylamine Succinate A-H Injection (RX) Epinephrine Lidocaine HCl with Epinephrine (RX) Lidocaine Hydrochloride Flumethasone Anaprime (RX) Flucort Solution (RX) Flunixin Meglumine Banamine Solution (RX) Flunixin Meglumine Inj. (RX) Flunixin Meglumine Solution (RX) Flunixin Injection (RX) Fluprostenol Sodium Equimate (RX) Follicle Stimulating Hormone F.S.H.-P Injectable (RX) Furosemide Disal 5% Injection (RX) Furosemide Injection (RX) Lasix Injectable Solution (RX) Furos-A-Vet Inj. (RX) Guaifensin Guailaxin (RX) Gecolate Injection (RX) Glycodex Injection (RX) Hyaluronate Sodium Equron (RX) Hyalovet (RX) Synacid (RX) Hyaluronic Acid Hyvisc (RX) Hyalovet (RX) Imidocarb Diproprionate Imizole Equine Inj. (RX) Isoflupredone Acetate Predef 2X (RX) Ivermectin Eqvalan Injection (RX) Ketoprofen Ketofen (RX) Luprostiol Sodium Equestrolin (RX) Mepivacaine Hydrochloride Mepivacaine Hcl Inj. (RX) Meclofenamic Acid Arquel (RX) Methocarbamol Robaxin-V Injectable (RX) Methylprednisolone Acetate Depo-Medrol (RX) Methylprednisolone Acetate Inj. (RX) Naproxen Equiproxin 10% Solution (RX) Neostigmine Methylsulfate Stiglyn 1-500 (RX) Oleate Sodium Osteum Solution 50 mg (RX) Orgotein Palosein (RX) Oxytocin Oxytocin Injection (RX) Xytocin Inject. (RX) Penicillin G Benzathine Combicillin, Combicillin-AG (R/O) Penicillin G Procaine Penicillin G Procaine Pro-Pen G in Aqueous Susp. (R/O) Pentazocine Lactate Talwin-V (RX) Phenylbutazone Bizolin Injection 20%(RX) Butazolidin Injectable (RX) Equi Bute Injection (RX) Equiphen (RX) Phen-Buta-Vet Inj. (RX) Phenylbutazone Inj. (RX) Robizone Injectable 20% (RX) Tevcodyne Injectable (RX) Therazone Inj. (RX) Pituitary Luteinizing P.L.H. Injectable (RX) Hormone Polysulfated Glycosamino-Adequan Injectable (RX) glycan Pralidoxime Chloride Protopam (RX) Prednisolone Ramosone (RX) Prednisolone Acetate Meticortelone Susp. (RX) Prednisolone Sodium Prednisolone Inj. (RX) Succinate Solu-Delta Cortef (RX) Prednisolone Tertiary Hydeltrone-TBA Butylacetate Suspension (RX) Prednisone Meticorten (RX) Procaine Penicillin G Crysticillin 300 A. S. Veterinary (R/O) Crystaline Pro Penicillin G (RX) Microcillin-Ag (OTC) Procaine Penicillin G (OTC) Penicillin G Procaine (OTC) Promazine Hydrochloride Promazine Injectable (RX) Sparine Injection (RX) Tranquazine Injection (RX) Prostalene Synchrocept Solution (RX) Pyrilamine Maleate Histavet-P (RX) Pyrilamine Maleate Injection (RX) Sodium Hyaluronate Equron (RX) Hylortin V (RX) Hyvisc (RX) Legend (RX) Sodium Pentobarbital Somnopentyl Injection (RX) Sodium Selenite E-SE (RX) Vitamin E Sodium Thiamylal Anestatal Inj. (RX) Sodium Thiamylal Injection (RX) Surital (RX) Stanozolol Winstrol-V (RX) Sulfadiazine Di-Trim 48% Inj. (RX) Trimethoprim Tribrissen 48% Inj. (RX) Sulfadimethoxine Agribon Inj. 40% (R/O) Tetracycline Tetracycline Inj. (RX) Thialbarbitone Sodium Kemithal L.A. (RX) Ticarcillin Disodium Ticillin (RX) Tolazine Hydrochloride Tolazine Injection (RX) Triamcinolone Acetonide Triamcinolone Susp. (RX) Vetalog Inj. (RX) Triflupromazine Vetame Inj. (RX) Hydrochloride Tripelennamine Hydro-Re-covr Injectable (RX) chloride Xylazine Hydrochloride Anased (RX) Chanizine Inj. (RX) Rompun Injectable (RX) Sedazine (RX) ORAL USE Altrenogest Regu-Mate (RX) Cambendazole Camvet Horse Wormer Paste 45% (OTC) Camvet Horse Wormer Pellets (OTC) Camvet Suspension Horse Wormer (RX) Chlorhexidine Nolvasan Tabs/Suspension (OTC) Dihydrochloride Chlortetracycline Chlorachel Premixes (OTC) Calcium Complex Chlorachel-100 (OTC) Clenbuterol Hydrochloride Ventipulmin Syrup (RX) Dexamethasone Azium Boluses (RX) Azium Oral Solution (RX) Azium Powder (RX) Dichlorvos Equigard (OTC) Dithiazanine Iodide Dizan Suspension with Piperazine Citrate Piperazine (OTC) Doxylamine Succinate A-H Tablets (RX) Febantel Rintal Paste (OTC) Rintal Suspension (OTC) Fenbendazole Panacur Suspension 10% (OTC) Safe-Guard Panacur (OTC) Safe-Guard Panacur Paste (OTC) Flunixin Meglumine Banamine Granules (RX) Banamine Paste (RX) Griseofulvin Fulvicin U/F Bolus Veterinary (RX) Fulvicin U/F Powder (RX) Iodochlorhydroxyquin Rheaform Bolus (RX) Ivermectin Eqvalan (RX) Eqvalan Paste 1.8% (OTC) Levamisole Hydrochloride Ripercol L-Piperazine (RX) Piperazine Dihydrochloride Ripercol L-Piperazine Sol. (RX) Mebendazole Telmin Oral Susp.(RX) Telmin Equine Wormer (RX) Telmin Syringe Formula (OTC) Mebendazole Telmin B (RX) Trichlorfon Telmin-B Paste (OTC) Meclofenamic Acid Arquel (RX) Moxidectin Quest Oral Gel (OTC) Naproxen Equiproxen Granules (RX) Neomycin Sulfate Biosol Soluble Powder (OTC) Oxfendazole Benzelmin/Syanthic Powder (R/O) Benzelmin/Synanthic Horse Wormer Pellets (R/O) Benzelmin/Syanthic Paste (R/O) Benzelmin/Syanthic Susp. (R/O) Oxfendazole Benzelmin Plus Paste (OTC) Trichlorfon Oxibendazole Anthelcide EQ Paste (OTC) Anthelcide EQ Suspension (RX) Phenothiazine Parvex Plus (RX) Piperazine-Carbon Disulfide Phenothiazine Dyrex T.F.(RX) Piperazine Dihydrochloride Trichlorfon Phenylbutazone Bizolin Tabs/Boluses (RX) Butatron Gel (RX) Butazolidin Granules (RX) Butazolidin Bolus (RX) Butazolidin Paste (RX) Equi Bute Tablets (RX) Equiphen Paste (RX) Equipalazone (RX) Phen-Buta-Vet Tablets (RX) Phenylbutazone Tablets (RX) Robizone-V (RX) Tevcodyne (RX) Therazone Tablets (RX) Piperazine Adipate Piperazine Adipate 100% (OTC) Piperazine Carbon Disulfide Parvex Bolus (OTC) Parvex Suspension (RX) Promazine Hydrochloride Promazine Granules (RX) Pyrantel Pamoate Banminth-P Paste (OTC) Strongid T (R/O) Pyrantel Tartrate Banminth (5.66 gm)(OTC) Pyrantel Tartrate Premix (OTC) Purina Horse & Colt Wormer Med (OTC) Strongid C (OTC) Sodium Sulfamethazine Sulmet (OTC) Stanozolol Winstrol-V (RX) SulfadiazineDI-Trim 400 Paste (RX) Trimethoprim Tribrissen 400 Oral Paste (RX) Uniprim Powder (RX) Thiabendazole Equizole A Packets (RX) Equizole Horse Wormer (RX) Equizole 50% Horse Wormer Paste (OTC) Equizole Wormer Pellets (OTC) Purina Horse Wormer Medicated (OTC) Thibenzole 300 Medicated (OTC) Thiabendazole Equizole A (RX) Piperazine Phosphate Thiabendazole Equizole A Liquid (RX) Piperazine Citrate Thiabendazole Equizole B (RX) Trichlorfon Tioxidazole Tiox Granules (OTC) Tiox Paste (OTC) Triamcinolone Acetonide Vetalog Oral Powder (RX) Trichlorfon Dyrex Cap- Tab 200 (RX) Purina Bot Control (OTC) Triflupromazine Vetame Tablets (OTC) Hydrochloride TOPICAL USE Balsam Peru Oil Trypzyme Aerosol (OTC) Trypsin Chlorhexidine Diacetate Nolvasan Germicidal Ointment (OTC) Copper Naphthenate Kopertox (OTC) Thrush-XX (OTC) Cuprimyxin Unitop Topical 0.5% Cream (RX) Dimethyl Sulfoxide Domoso Gel (RX) Domoso Sol. (RX) Furazolidone Furall Aerosol Powder (OTC) Topazone Aerosol Powder (OTC) Hydrocortisone Acetate Kymar Ointment (RX) Neomycin Palmitate Trysin- Chymotrypsin Isoflupredone Neo Predef Eye-Ear-Topical Neomycin Sulfate Ointment (RX) Isoflupredone Acetate Tritop Ointment (RX) Tetracaine HydrochlorideNeomycin Sulfate Nitrofurazone Fura Ointment (OTC) Fura-Septin (OTC) Nitrofurazone Powder (OTC) Nitrofurazone Ointment (OTC) Nitrofurazone Dressing (OTC) NFZ Dressing (OTC) NFZ Wound Powder (OTC) Nitrofurantoin Dantafur (RX) Oxytetracycline Hydro-Terramycin Ophthalmic Ointment (OTC) chloride Polymyxin B Sulfate INHALATION USE Halothane Fluothane (RX) Isoflurane Aerrane (RX) Isoflurane, USP (RX) Isoflo (RX) INTRAUTERINE USE Amikacin Sulfate Amiglyde-V (RX) Amikacin Intrauterine (RX) Chlorhexidine Nolvasan Effervescent Uterine (OTC) Dihydrochloride Gentamicin Sulfate Gentocin Solution (RX) Gentamicin Intrauterine (RX) Gentamicin Sulfate Solution (RX) Gentamex 100 Intrauterine (RX) Gentaglyde Sol. (RX) Sulfamethazine Sulmet Oblets (OTC)